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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 485-300-3 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 2007-11-21 till 2007-12-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study under GLP without deviations.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- A preliminary test was performed first to detect the highest application solution. The maximum technically applicable concentration was found to be 50%. Based on the results of this preliminary test the test item was assayed at three concentrations: 12,5%, 25%, 50% (w/v).
- No. of animals per dose:
- 5 mice per test group; 3 test groups (3 different concentrations) and 1 Negative Control Group (vehicle) were tested.
- Positive control substance(s):
- other: p-Phenylenediamine
- Positive control results:
- The stimulation index observed in the historical positive control group of the BSL study no. 073846 with 1% p-Phenylendiamine was 8.1.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Table 3: Radioactive determination of the test substance groups. If not noted individually, results include both lymph nodes of an animal.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The EC3 value (derived by linear interpolation) for the test substance could not be stated, as all measure points were below the stimulation index of three. Considering the reported data of this sensitization test it can be stated that the test item causes no reactions identified as sensitization, as the stimulation index was below 3.0 for each concentration tested.
Reference
Summary Results:
The stimulation index at a conc. of 12.5 % was 0.7,
The stimulation index at a conc. of
25 % was 0.9Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
- In a Local Lymph Node Assay ( OECD 429 adopted: 24th
April 2002) with mice none of the three tested concentrations of the test
item reached the stimulation index of 3.
All animals survived throughout the test period without showing any clinical sign.
Migrated from Short description of key information:
The substance is not sensitising. The stimulation index < 3.0 for each concentration tested.
Justification for selection of skin sensitisation endpoint:
only existing but sufficient study
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
- Migrated from Short description of key information:
substance is not sensitising.
Justification for classification or non-classification
According to the GHS criteria, listed in Annex I, the substance does not have to be classified as a hazardous substance regarding sensitisation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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